FTC Charges that Evidence Supporting Benefits of Probiotics Falls Short

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The Dannon Company, Inc. has agreed to settle Federal Trade Commission charges of deceptive advertising and drop claims that allegedly exaggerated the health benefits of its Activia yogurt and DanActive dairy drink. These two popular Dannon products contain beneficial bacteria known as probiotics. Dannon will stop claiming that one daily serving of Activia relieves irregularity, and that DanActive helps people avoid catching colds or the flu.

According to the FTC’s complaint, Dannon claimed in nationwide advertising campaigns that DanActive helps prevent colds and flu, and that one daily serving of Activia relieves temporary irregularity and helps with “slow intestinal transit time.” In television, Internet, and print ads, as well as on product packaging, Dannon also stated that there was scientific proof to back up these claims.

As part of its ongoing efforts to make sure that marketers do not overstate the health benefits of their products, the FTC charged that Dannon’s ads were deceptive because it did not have substantiation for its claims. The Commission also charged that Dannon’s claims that Activia and DanActive were clinically proven were false.

“These types of misleading claims are enough to give consumers indigestion,” said FTC Chairman Jon Leibowitz. “Consumers want, and are entitled to, accurate information when it comes to their health. Companies like Dannon shouldn’t exaggerate the strength of scientific support for their products.”

In one television advertisement for Activia yogurt, actress Jamie Lee Curtis lounges on a couch holding a newspaper. She tells viewers that many people suffer from irregularity, and that “our busy lives sometimes force us to eat the wrong things at the wrong time.” She reassures viewers that Activia can help.

The screen then shows a woman’s midsection, on which a clump of yellow-green balls is superimposed, representing the transit of food through the digestive system. The balls merge into a downward-facing arrow, which moves off the screen while a man’s voice states, “With the natural culture Bifidus Regularis, Activia eaten every day is clinically proven to help regulate your digestive system in two weeks.”

According to the FTC’s complaint, Dannon’s advertisements for DanActive conveyed to consumers that drinking the product reduces the likelihood of getting a cold or flu. In one television ad, a boy takes an exam at school, plays baseball in the rain, and gets thrown to a mat during a martial arts class. The color drains from his face and body as he arrives home, and his mother hands him a bottle of DanActive. A graphic shows Dannon’s probiotic ingredient, L. casei Immunitas, plugging holes in the intestinal wall so that purple balls bounce off the wall rather than entering the holes. As a voiceover assures that DanActive is “clinically proven to help strengthen your body’s defenses,” color returns to the boy’s face and body and he is surrounded by a new, protective, yellow shield as he runs out of the house.

Under the proposed settlement:

Dannon is prohibited from claiming that any yogurt, dairy drink, or probiotic food or drink reduces the likelihood of getting a cold or the flu, unless the claim is approved by the Food and Drug Administration. Although companies usually do not need FDA approval of their health claims to comply with the FTC Act, the FTC determined in this case that requiring FDA approval will give Dannon clearer guidance going forward, and help ensure that it complies with the settlement order.

Dannon may not claim that Activia yogurt will relieve temporary irregularity or help with slow intestinal transit time, unless the claim is not misleading and the ad conveys that three servings of Activia yogurt must be eaten each day to obtain these benefits. Dannon may claim that eating fewer than three servings a day provides these benefits only if the company is relying on two well-designed human clinical studies substantiating that the claim is true.

Dannon may not claim that any other yogurt, dairy drink, or probiotic food or drink will relieve temporary irregularity or help with slow intestinal transit time unless the claim is not misleading and the company has two well-designed human clinical studies that substantiate the claim.

Dannon may not make any other claims about the health benefits, performance, or efficacy of any yogurt, dairy drink, or probiotic food or drink, unless the claims are true and backed by competent and reliable scientific evidence. Dannon also is prohibited from misrepresenting the results of any tests or studies.

The FTC worked in close coordination with 39 state attorneys general, who are simultaneously announcing the resolution of their own inquiries into Dannon’s advertising of DanActive and Activia. Dannon has agreed to pay the states $21 million to resolve these investigations.

The FTC vote to approve the administrative complaint and proposed consent agreement was 5-0. The FTC will publish an announcement regarding the agreement in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through January 18, 2011, after which the FTC will decide whether to make it final. Consumers can file a public comment online.

Copies of the complaint, the proposed consent agreement, and an analysis of the agreement to aid in public comment are available from both the FTC’s website at http://www.ftc.gov and the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, DC 20580.

NOTE: The Commission issues an administrative complaint when it has reason to believe that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the respondent has actually violated the law. The consent agreement is for settlement purposes only and does not constitute admission by the respondent of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,800 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics.